Notification Process, the requirements and common mistakes Brian Murphy
Biocide Enforcement and Product Notifications
12th March 2020
Overview
• Process for Notification of a new product & Trivial Amendments
• Application form and the Biocidal Product Register
• Common issues with applications
• The application queue
• Biocide Notifications Procedure
• Useful links
An Roinn Talmhaíochta, Bia agus Mara │ Department of Agriculture, Food and the Marine
Product Notification: First Steps
1. Check the Online register - Duplication of product names is prohibited
2. Check the ECHA Active Substance review programme - Check the status or date of approval for the AS/PT combination
3. Consult our ‘How to Guide’ - Mock application form explains how the form must be filled out
4. Consult the FAQ document - The FAQ is updated regularly
5. Once these steps are complete begin preparing a Notification application
An Roinn Talmhaíochta, Bia agus Mara │ Department of Agriculture, Food and the Marine
Product Notification: Requirements
Applications should include:
• A fully complete application form
• Safety data sheets for the Active Substance(s) and all co-formulants
• Safety data sheet for the product
• Letter of Access or Supply for the Active Substance(s)
• Draft Irish Label
• Completed CCS Form*
*A completed CCS form is required for all new applicants so we can set them up on our system
An Roinn Talmhaíochta, Bia agus Mara │ Department of Agriculture, Food and the Marine
Received Product Notification Applications • All notification applications must be sent to:
• Biocide Notifications will acknowledge receipt of the application and issue a tracker number
• At the same time an Invoice is issued • €300 fee applies
• Only when the invoice is paid will an application be considered for processing
• Applications completed on a first come first served basis
An Roinn Talmhaíochta, Bia agus Mara │ Department of Agriculture, Food and the Marine
Evaluation of a Notification Application • When processing an application
• Data is evaluated
• Added to our database in a specific format
• An application under query email is generated outlining: • Data gaps
• The PCS number to be added to the final label
• +/- other comments/ further information
• Reminder emails are issued • In the previous 3 months the average processing time was 11 weeks
• Applications are rejected if the data is not submitted • Require re application and new notification fee
An Roinn Talmhaíochta, Bia agus Mara │ Department of Agriculture, Food and the Marine
Trivial Amendments
• Similar process for Trivial Amendments • Acknowledgement and Invoice
A Trivial Amendments is required if a change is made to any part of the application form*
• €300 fee applies
*Changes to the distributor company and/or Account holder
An Roinn Talmhaíochta, Bia agus Mara │ Department of Agriculture, Food and the Marine
Trivial Amendment Submission Requirements
• Products that have been notified in the previous 3 years • Application form with the completed section(s) where the change(s) is made • OR resubmit the previous application form with the amendment highlighted
in RED • Updated label/SDS/Letter of Access or Supply if necessary
• Products notified for more than 3 years • Will require a full application (as a new notification) • To complete our records
• This will be requested at processing – Application Under Query email
An Roinn Talmhaíochta, Bia agus Mara │ Department of Agriculture, Food and the Marine
Changes that don’t require a fee
• Label or SDS update • Change of classification
• Update to artwork
• Change of colour scheme/Picture
• Changes to the Distribution Company or the Account Holder will be considered updates
• Specific form available on the website
• CCS form
An Roinn Talmhaíochta, Bia agus Mara │ Department of Agriculture, Food and the Marine
Application Form Available Since July 2019
An Roinn Talmhaíochta, Bia agus Mara │ Department of Agriculture, Food and the Marine
Consult the Mock Completed Application Form
Application Form Explained
• Section 1: Notification holder = Entity responsible for making the product available for sale and use
• CCS form for new companies
• Section 2: Product Information • Product type = ECHA website • Formulation type = OECD website
• Section 3: Product Manufacturer = Product formulator
• Section 4: Additional Product Info • Clarify the exact product uses
• Section 5: Labelling
An Roinn Talmhaíochta, Bia agus Mara │ Department of Agriculture, Food and the Marine
Application Form Explained
• Section 6: Packaging Information • Pack type – exact description
• Packaging material
• Pack size
• Section 7: Primary Distributor = name and address of the Irish central distribution point(s) & Marketing Company
• Section 8: Account holder = Entity responsible for paying the notification fee and annual fees
(CCS form for new customers)
An Roinn Talmhaíochta, Bia agus Mara │ Department of Agriculture, Food and the Marine
Application form Explained
• Section 9: Active Substance Manufacturer = must be listed on the Article 95 list
• Section 10: Product Specifications • Wipe Information
• Active substance VS Impurity
Section 1
Section 2 & 4
Section 6
Section 9 & 10
Section 3
Section 7
Section 8
Common Issues with the Application Form • Sections left blank
• All sections must be completed
• Form is formatted to match our database
• No active substance purity figure included
• Section 10: Formulation table • Content of the RED column not adding up to 1000.00
• Content of the GREEN column not adding up to 100.00
• Active substance content not presented as the pure active substance
• Active substance impurity not included as a co-formulant
• Active substance content not identical to the product label
• CAS numbers on the application form not matching the review programme
An Roinn Talmhaíochta, Bia agus Mara │ Department of Agriculture, Food and the Marine
Other common Issues • Incorrect SDSs attached
• The Safety Data Sheet (SDS) quotes a different CAS no to the application form/review programme
• The SDS quotes the incorrect Product name or Active Substance name • DPD classifications are out of date • CLP link between the section 2 of the SDS and the Label • Required PPE not specified
• Letter of access or supply • Approved AS require a letter of access to the Active substance dossier • Where the AS is still in review a letter of supply will suffice • Confirmation must show link back to the Article 95 Company
• Intermediary companies
An Roinn Talmhaíochta, Bia agus Mara │ Department of Agriculture, Food and the Marine
Labelling issues Elements missing from submitted labels
• Exact name and content of each active substance • Exactly as it appears on the application form
• The approval number • Must be indelible ink
• The name and address of the Notification holder • Other company names can appear in addition, if required
• Direction for use of the product
• User category details
• CLP classification as per the Product SDS (section 2) • The following text is missing:
‘Use Biocides Safely and Sustainably. It is illegal to use this product for uses or in a manner other than that prescribed on this label’
An Roinn Talmhaíochta, Bia agus Mara │ Department of Agriculture, Food and the Marine
Labelling Issues (2)
It is the responsibility of the notification holder to label in accordance with Art 69 of the Biocidal Product regulation
• Labels are not approved at notification – Checked on inspection
• Some labels mislead the risk associated with the product
• Prohibited phrases • ‘Non toxic’ • ‘Natural’ • ‘Harmless’ • ‘Low-risk biocidal product’ • Phrases of a similar indication
• Biocidal products should not be packaged in a way in which they may be mistaken for Food and shall not be attractive to children
An Roinn Talmhaíochta, Bia agus Mara │ Department of Agriculture, Food and the Marine
Packaging Issues: CLP
• Products classified as Corrosive and available to the general public • Child resistant fastenings • Tactile warnings
• Identification of non compliant products on inspection
will result in product removal/market recall
More information is available below
• ECHA website:
https://echa.europa.eu/regulations/clp/labelling/specific-labelling-and-packaging-situations
• HSA website:
https://www.hsa.ie/eng/Publications_and_Forms/Publications/Chemical_and_Hazardous_Substances/CLP_info_sheet.pdf
An Roinn Talmhaíochta, Bia agus Mara │ Department of Agriculture, Food and the Marine
The Application Queue
• The application queue had been very long • Staffing and recruiting issues
• Allowing reminder emails and excessive time to submit data
• Queue has now shortened • No longer continuing the same level of reminders
• Applications are being rejected to prevent additional delays
An Roinn Talmhaíochta, Bia agus Mara │ Department of Agriculture, Food and the Marine
Application Queue Application
date Tracker
No Company
Name Invoice Issued
Invoice Paid Product Name Processer
1/01/2019 1234 Company A Y 2/09/2020 Hand sanitiser
1/01/2019 1235 Company B Y 28/01/2020 Germ killer
1/01/2019 1236 Company C Y 11/02/2020 Wood preserver
1/01/2019 1237 Company D Y 18/02/2020 Insect repellent
An Roinn Talmhaíochta, Bia agus Mara │ Department of Agriculture, Food and the Marine
Week 1- All applications are received and added to the queue, invoices are issued
An Roinn Talmhaíochta, Bia agus Mara │ Department of Agriculture, Food and the Marine
Application Queue Application
date Tracker
No Company
Name Invoice Issued
Invoice Paid Product Name Processer
1/01/2019 1234 Company A Y 2/09/2020 Hand sanitiser
1/01/2019 1235 Company B Y 28/01/2019 Germ killer
1/01/2019 1236 Company C Y 11/02/2020 Wood preserver
1/01/2019 1237 Company D Y 18/02/2020 Insect repellent
Week 4- Company B pays the invoice
An Roinn Talmhaíochta, Bia agus Mara │ Department of Agriculture, Food and the Marine
Application Queue Application
date Tracker
No Company
Name Invoice Issued
Invoice Paid Product Name Processer
1/01/2019 1234 Company A Y 2/09/2020 Hand sanitiser
1/01/2019 1235 Company B Y 28/01/2019 Germ killer
1/01/2019 1236 Company C Y 11/02/2020 Wood preserver
1/01/2019 1237 Company D Y 18/02/2020 Insect repellent
Week 5 - Company B’s application is claimed and processing begins - an application under query email is sent
XX
An Roinn Talmhaíochta, Bia agus Mara │ Department of Agriculture, Food and the Marine
Application Queue Application
date Tracker
No Company
Name Invoice Issued
Invoice Paid Product Name Processer
1/01/2019 1234 Company A Y 2/09/2020 Hand sanitiser
1/01/2019 1235 Company B Y 28/01/2019 Germ killer
1/01/2019 1236 Company C Y 11/02/2019 Wood preserver
1/01/2019 1237 Company D Y 18/02/2020 Insect repellent
Week 6 - Company C pays the invoice, Company B has not responded so Company C processing begins
XX
XX
An Roinn Talmhaíochta, Bia agus Mara │ Department of Agriculture, Food and the Marine
Application Queue Application
date Tracker
No Company
Name Invoice Issued
Invoice Paid Product Name Processer
1/01/2019 1234 Company A Y 2/09/2020 Hand sanitiser
1/01/2019 1235 Company B Y 28/01/2019 Germ killer
1/01/2019 1236 Company C Y 11/02/2019 Wood preserver
1/01/2019 1237 Company D Y 18/02/2019 Insect repellent
Week 7 - Company D pays the invoice but Company B & C have submitted poor quality applications, additional time and correspondence takes up time which delays starting Company D’s application
XX
XX
An Roinn Talmhaíochta, Bia agus Mara │ Department of Agriculture, Food and the Marine
Application Queue Application
date Tracker
No Company
Name Invoice Issued
Invoice Paid Product Name Processer
1/01/2019 1234 Company A Y 2/09/2020 Hand sanitiser
1/01/2019 1235 Company B Y 28/01/2019 Germ killer
1/01/2019 1236 Company C Y 11/02/2019 Wood preserver
1/01/2019 1237 Company D Y 18/02/2019 Insect repellent
Week 8 to 11 - Still unable to find time to start Company's D application due to follow-up with other companies, continued emails and phone calls
XX
XX
An Roinn Talmhaíochta, Bia agus Mara │ Department of Agriculture, Food and the Marine
Application Queue Application
date Tracker
No Company
Name Invoice Issued
Invoice Paid Product Name Processer
1/01/2019 1234 Company A Y 2/09/2020 Hand sanitiser
1/01/2019 1235 Company B Y 28/01/2019 Germ killer
1/01/2019 1236 Company C Y 11/02/2019 Wood preserver
1/01/2019 1237 Company D Y 18/02/2019 Insect repellent
Week 13 - Company C submits the correct information and the product is notified
XX
XX Complete
An Roinn Talmhaíochta, Bia agus Mara │ Department of Agriculture, Food and the Marine
Application Queue Application
date Tracker
No Company
Name Invoice Issued
Invoice Paid Product Name Processer
1/01/2019 1234 Company A Y 2/09/2020 Hand sanitiser
1/01/2019 1235 Company B Y 28/01/2019 Germ killer
1/01/2019 1236 Company C Y 11/02/2019 Wood preserver
1/01/2019 1237 Company D Y 18/02/2019 Insect repellent
Week 14 - Company D is claimed and processing begins – They read the guidance, all the information is correct and an application under query email is sent to request the final label
XX
XX Complete
XX
An Roinn Talmhaíochta, Bia agus Mara │ Department of Agriculture, Food and the Marine
Application Queue Application
date Tracker
No Company
Name Invoice Issued
Invoice Paid Product Name Processer
1/01/2019 1234 Company A Y 2/09/2020 Hand sanitiser
1/01/2019 1235 Company B Y 28/01/2019 Germ killer
1/01/2019 1236 Company C Y 11/02/2019 Wood preserver
1/01/2019 1237 Company D Y 18/02/2019 Insect repellent
Week 16 - Company D submit the product label and the product is notified
XX
XX Complete
XX Complete
An Roinn Talmhaíochta, Bia agus Mara │ Department of Agriculture, Food and the Marine
Application Queue Application
date Tracker
No Company
Name Invoice Issued
Invoice Paid Product Name Processer
1/01/2019 1234 Company A Y 2/09/2020 Hand sanitiser
1/01/2019 1235 Company B Y 28/01/2019 Germ killer
1/01/2019 1236 Company C Y 11/02/2019 Wood preserver
1/01/2019 1237 Company D Y 18/02/2019 Insect repellent
Week 18 - Company B submits the requested information and the product is notified
XX
XX Complete
XX Complete
Complete
An Roinn Talmhaíochta, Bia agus Mara │ Department of Agriculture, Food and the Marine
Application Queue Application
date Tracker
No Company
Name Invoice Issued
Invoice Paid Product Name Processer
1/01/2019 1234 Company A Y 14/07/2019 Hand sanitiser
1/01/2019 1235 Company B Y 28/01/2019 Germ killer
1/01/2019 1236 Company C Y 11/02/2019 Wood preserver
1/01/2019 1237 Company D Y 18/02/2019 Insect repellent
Week 24 - Company A pays the invoice
XX
XX Complete
XX Complete
Complete
Application Queue
• Timelines for the current example
• Multiplying this example • 22 product types
• Over 5000 products currently on our register
• Approximately 800 applications received annually
An Roinn Talmhaíochta, Bia agus Mara │ Department of Agriculture, Food and the Marine
Payment length Processing length Total length
Company A 24 weeks - -
Company B 4 weeks 14 weeks 18 weeks
Company C 6 weeks 7 weeks 13 weeks
Company D 7 weeks 2 weeks 16 weeks
Expectation…
Application submitted
Application completed and product notified
Applicant submits documents as requested
Biocide Notifications request updated label with PCS number
… vs Reality Application submitted
Application is completed and product notified
Applicant submits documents as requested
Biocide Notifications request additional data
Applicant submits some more data Biocide Notifications
request outstanding data
Applicant submits the data but contains numerous errors Biocide Notifications
requests clarifications
Poor quality information submitted
Biocide Notifications set deadline for application rejection
New Timelines for Notifications • Applications to be acknowledged and invoices issued within 2 - 4 weeks of
submission • Time for invoice payment & time to allow processing begin • Unpaid invoice will be cancelled and the application rejected
• During processing “Applications Under Query” is issued with a max 3 week
deadline to submit outstanding data • Guidance included in the query email
• After 3 weeks a Final Reminder email issued with a 1 week deadline for
outstanding data
• Applications are being rejected after 4 weeks • No response or failure to submit the requested data
An Roinn Talmhaíochta, Bia agus Mara │ Department of Agriculture, Food and the Marine
An Roinn Talmhaíochta, Bia agus Mara │ Department of Agriculture, Food and the Marine
Documents of Interest: PRCD Website
Documents of Interest: PRCD Website
An Roinn Talmhaíochta, Bia agus Mara │ Department of Agriculture, Food and the Marine
Biocides Page of the PRCD Website
Register
Info on Notifications
Documents of Interest: PRCD Website
Guidance on Applications
Mock Completed Form
FAQ
Document requirements for a notification Product updates & Trivial
amendments
Useful Links
• Notification Guidance – ‘How to Guide’
http://www.pcs.agriculture.gov.ie/biocides/biocidalproducts/nationalnotificationapplications/notifications-howtoguide/
• PRCD Product Notification page
http://www.pcs.agriculture.gov.ie/biocides/biocidalproducts/nationalnotificationapplications/
• Notified Biocidal Product Register
https://publicapps.agriculture.gov.ie/prs/home
• ECHA Active Substance Review Programme
https://echa.europa.eu/information-on-chemicals/biocidal-active-substances
• Article 95 list of compliant Active Substance Manufacturers
https://echa.europa.eu/information-on-chemicals/active-substance-suppliers
An Roinn Talmhaíochta, Bia agus Mara │ Department of Agriculture, Food and the Marine